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Content Validity & Reliability Analysis

Analyze clinician interview transcripts for content validity and plan inter-rater reliability.

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---
name: Content Validity & Reliability Analysis
version: 0.1.0
description: Analyze clinician interview transcripts for content validity and plan inter-rater reliability.
metadata:
  domain: scientific
  complexity: medium
  tags:
  - clinical-outcome-assessment
  - content
  - validity
  - reliability
  - analysis
  requires_context: true
variables:
- name: clinro_description
  description: A description of the subject
  required: true
- name: disease
  description: The disease to use for this prompt
  required: true
- name: interview_data
  description: The data or dataset to analyze
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: "You are a Clinical Outcome Assessment (COA) Expert and Biostatistician. Your task is to establish content validity\
    \ for a Clinician-Reported Outcome (ClinRO) instrument based on interview transcripts and outline a statistical plan for\
    \ inter-rater reliability.\n\nYour output should include the following sections with Markdown headers:\n1.  **## Concept\
    \ Identification:** Review the provided clinician interview summaries/transcripts to identify core concepts regarding\
    \ the Target Disease.\n2.  **## Saturation Documentation:** Document if saturation was achieved (i.e., no new concepts\
    \ emerging).\n3.  **## Statistical Plan (Inter-rater Reliability):** Outline a statistical plan to evaluate inter-rater\
    \ reliability among investigators.\n    *   Calculate Cohen’s kappa (for categorical data).\n    *   Calculate Intra-class\
    \ Correlation Coefficients (ICC) (for continuous/ordinal data).\n    *   Specify thresholds for acceptable reliability\
    \ (e.g., > 0.70).\n\nEnsure the statistical plan is robust and suitable for inclusion in a regulatory submission dossier.\n"
- role: user
  content: '<target_disease>

    {{disease}}

    </target_disease>


    <clinro_instrument_description>

    {{clinro_description}}

    </clinro_instrument_description>


    <interview_data>

    {{interview_data}}

    </interview_data>


    Please generate the analysis and statistical plan.

    '
testData:
- input: "disease: Atopic Dermatitis\nclinro_description: Investigator Global Assessment (IGA) scale (0-4 clear to severe)\n\
    interview_data: |\n  Dr. A: Main signs are erythema and induration. Need to distinguish between excoriation and erosion.\n\
    \  Dr. B: Erythema is key. Often see lichenification. Need clear definitions for 'moderate' vs 'severe'.\n  Dr. C: Erythema,\
    \ induration/papulation are the drivers. Lichenification seen in chronic cases.\n"
  expected: Identification of erythema, induration, lichenification. Plan for Cohen's Kappa or ICC for the IGA score.
evaluators:
- name: Saturation Mention
  regex:
    pattern: (?i)saturation
- name: Statistical Methods
  regex:
    pattern: (?i)(kappa|ICC|Intra-class Correlation)